This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In your response of May 26, 2017, you acknowledged the significance of the CGMP observations. You did not commit to any specific corrective actions.

1.Your firm failed to establish a quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(a) and (d)).

Your firm lacks an adequate quality unit.

You have not established written procedures for numerous functions, including but not limited to complaints, deviations, change control, supplier qualification, and batch release.

You utilize contract manufacturers to manufacture your over-the-counter (OTC) drug products distributed to the United States. You have a quality agreement between your firm and your contract manufacturer that states your contract manufacturer is “responsible for quality related to the manufacture of the product produced and supplied.” However, you have released some drugs for which neither you nor your contract manufacturer conducted release tests for identity and strength of active ingredients. As a result, some of your drugs are distributed without confirmation that they meet specifications for identity and strength of their active ingredients.

In response to this letter, provide your written procedures establishing an adequate quality control unit with the authority to carry out its responsibilities, including but not limited to:

Written procedures defining your batch review and release process; and

Written procedures establishing your supplier and contractor qualification, selection, and oversight program, including procedures to ensure compliance with drug CGMP at all stages of manufacturing processing packing, or holding.

2.Your firm failed to have written procedures describing the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials, which shall be representatively sampled, examined or tested upon receipt and before use in packaging or labeling of a drug product (21 CFR 211.122(a)).

You released packaging and labeling materials for use in drug product manufacturing without written procedures. You also stated to our investigator that you examine only (b)(4) units of packaging material, regardless of the batch size. You had no data to demonstrate that (b)(4) units were a representative sample.

In response to this letter, provide an adequate procedure for releasing packaging and labeling materials for use in manufacturing.

Use of Contract Manufacturers

All drugs, including OTC drugs, must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce, regardless of agreements in place with your contract facilities. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity.

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and for ensuring ongoing CGMP compliance.

Conclusion

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

FDA placed your firm on Import Alert 66-40 on August 23, 2017.

Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Amaros Co., Ltd., Jungwon-gu, 560 Dunchon-daero, Seongnam-si, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.